Chest pain in patients presenting to the emergency department (ED) present a clinical dilemma: transfer for emergent coronary revascularization, admit overnight for cardiac telemetry and stress testing, or discharge home with medical follow-up. In this proposal, we hypothesize that a novel thrombus-specific Spectral Computed Tomography (Multicolored CT) nanoparticle (i.e., NanoK) approach for direct rapid assessment of coronary disease in the ED could help resolve this clinical dilemma. This project, which is led by Ocean NanoTech in collaboration with Washington University, will complete development of a GLP-/GMP-ready 1- fibrin NanoK product candidate suitably advanced for GLP stability and toxicity testing to support an FDA IND. This NanoK platform technology offers unique benefits for diagnosis and treatment of acute coronary disease that could improve healthcare outcomes and reduce costs.

Public Health Relevance

Chest pain in patients presenting to the emergency department (ED) present a clinical dilemma: transfer for emergent coronary revascularization, admit overnight for cardiac telemetry and stress testing, or discharge home with medical follow-up. While the emergent need for cardiac catheterization is self evident from the presentation of some individuals, the determination of whether to admit or discharge a patient with an equivocal history and physical is often problematic. In lieu of missing a critical cardiac diagnosis, patients are admitted for myocardial evaluation and stress testing, which is inconvenient, costly and unnecessary in the majority of cases. In this proposal, we hypothesize that a novel thrombus-specific Spectral Computed Tomography (Multicolored CT) nanoparticle (i.e., NanoK) approach for direct rapid assessment of coronary disease in the ED could help resolve this clinical dilemma. This project describes the demonstration of the prototype concept in Phase 1 and the development, demonstration, and characterization of the clinical product candidate in Phase II. The overarching goal of this project, which is led by Ocean NanoTech in collaboration with Washington University, will be to complete development of a GLP- /GMP-ready 1-fibrin NanoK product candidate suitably advanced for GLP stability and toxicity testing to support an FDA IND. This NanoK platform technology offers unique benefits for diagnosis and treatment of acute coronary disease that could improve healthcare outcomes and reduce costs.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Small Business Technology Transfer (STTR) Grants - Phase II (R42)
Project #
5R42HL112518-02
Application #
8497716
Study Section
Special Emphasis Panel (ZRG1-SBIB-T (10))
Program Officer
Danthi, Narasimhan
Project Start
2012-07-01
Project End
2014-06-30
Budget Start
2013-07-01
Budget End
2014-06-30
Support Year
2
Fiscal Year
2013
Total Cost
$193,077
Indirect Cost
Name
Ocean Nanotech, LLC
Department
Type
DUNS #
155516987
City
Springdale
State
AR
Country
United States
Zip Code
72764
Wu, Lina; Wen, Xiaofei; Wang, Xiance et al. (2018) Local Intratracheal Delivery of Perfluorocarbon Nanoparticles to Lung Cancer Demonstrated with Magnetic Resonance Multimodal Imaging. Theranostics 8:563-574
Ross, Michael H; Esser, Alison K; Fox, Gregory C et al. (2017) Bone-Induced Expression of Integrin ?3 Enables Targeted Nanotherapy of Breast Cancer Metastases. Cancer Res 77:6299-6312
Lanza, Gregory M; Cui, Grace; Schmieder, Anne H et al. (2017) An unmet clinical need: The history of thrombus imaging. J Nucl Cardiol :
Esser, Alison K; Schmieder, Anne H; Ross, Michael H et al. (2016) Dual-therapy with ?v?3-targeted Sn2 lipase-labile fumagillin-prodrug nanoparticles and zoledronic acid in the Vx2 rabbit tumor model. Nanomedicine 12:201-11
Wang, Kezheng; Pan, Dipanjan; Schmieder, Anne H et al. (2015) Atherosclerotic neovasculature MR imaging with mixed manganese-gadolinium nanocolloids in hyperlipidemic rabbits. Nanomedicine 11:569-78
Pan, Dipanjan; Kim, Benjamin; Hu, Grace et al. (2015) A strategy for combating melanoma with oncogenic c-Myc inhibitors and targeted nanotherapy. Nanomedicine (Lond) 10:241-51
Wang, Kezheng; Pan, Dipanjan; Schmieder, Anne H et al. (2015) Synergy between surface and core entrapped metals in a mixed manganese-gadolinium nanocolloid affords safer MR imaging of sparse biomarkers. Nanomedicine 11:601-9
Goette, Matthew J; Lanza, Gregory M; Caruthers, Shelton D et al. (2015) Improved quantitative (19) F MR molecular imaging with flip angle calibration and B1 -mapping compensation. J Magn Reson Imaging 42:488-94
Goette, Matthew J; Keupp, Jochen; Rahmer, Jürgen et al. (2015) Balanced UTE-SSFP for 19F MR imaging of complex spectra. Magn Reson Med 74:537-43
Schmieder, Anne H; Caruthers, Shelton D; Keupp, Jochen et al. (2015) Recent Advances in (19)Fluorine Magnetic Resonance Imaging with Perfluorocarbon Emulsions. Engineering (Beijing) 1:475-489

Showing the most recent 10 out of 22 publications